Aims: To explore glucose lowering response to insulin initiation or switch to insulin glargine in obese and non‐obese individuals with type 2 diabetes mellitus (T2DM) and to examine weight gain and hypoglycaemic episodes in this group.
Methods:Post hoc subgroup analysis using data of obese and non‐obese participants from a large multi‐centre (4555 participants with T2DM), multi‐national 24‐week randomized controlled trial of investigator titrated insulin glargine versus patient self‐managed titrated insulin glargine. This analysis was carried out to compare two subgroups: obese (≥30 kg/m2) and non‐obese (<30 kg/m2) participants.
Results: The mean body mass index (BMI) values were 33.7 kg/m2(n = 1833) and 25.9 kg/m2(n = 2755) in obese and non‐obese subjects, respectively. There was a significant reduction in glycated haemoglobin (HbA1c) from baseline in both subgroups but no significant difference between subgroups (1.15 vs. 1.15%, p = 0.50). Overall, there was a 1.21 kg (s.d. 3.3) increase in weight in individuals who were non‐obese and a 1.08 kg (s.d. 3.9) increase in obese individuals (p = 0.67). There was no significant difference in the proportion of participants achieving an HbA1c of <7.0% at 6 months in both the subgroups (28.8 vs. 27.1%, p = 0.20). In multiple logistic regression, BMI was not a prognostic factor in achieving a target of HbA1c ≤ 7.0%. There was no significant difference in severe hypoglycaemic episodes between obese and non‐obese subgroups (1.3 vs. 1.0%); however, significantly more non‐obese individuals experienced nocturnal hypoglycaemic episodes(4.5 vs. 2.4%, p < 0.05).
Conclusions: In this study, treatment with insulin glargine in people with T2DM was associated with a significant reduction in HbA1c without differential increase in weight gain in obese and non‐obese subgroups. Rates of severe hypoglycaemia were not different between obese and non‐obese subgroups.